Colorecal NeoplasmsPhase 2TIROX2NCT00506571
Phase II Study of Irinotecan,Oxaliplatin Plus TS-1 in Untreated Metastatic Colorectal Cancer
A Phase 2 study testing S-1, irinotecan, oxaliplatin in people with Colorecal Neoplasms and Secondary, run by National Cancer Center, Korea at 1 site in South Korea.
Trial summary
Patients will be treated with irinotecan (150 mg/m2) followed by oxaliplatin (85 mg/m2) on day 1 and S-1 (80 mg/m2/day) from day 1 to 14 every 3 weeks. Patients will receive up to a planned treatment of maximum 12 cycles of chemotherapy. Response assessment will be performed every 2 cycles of chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorecal Neoplasms, Secondary
- What is being tested?
- S-1, irinotecan, oxaliplatin
- How many people
- 42 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2007to Jun 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed unresectable or metastatic colorectal cancer, not amenable to surgery or radiation treatment for curative intent
- At least one unidimensional measurable lesion
- ECOG performance status 0-2.
- No prior chemotherapy in metastatic settings, but adjuvant or neo-adjuvant treatment for non-metastatic (M0) disease is allowed if completed at least 6 months prior to initiation of study treatment
- Adequate major organ functions
- Give written informed consent
Who cannot join
- Prior systemic chemotherapy for metastatic disease
- Prior treatment with oxaliplatin or irinotecan
- Prior radiotherapy is permitted if it was not administered to target lesions selected for this study and provided it has been completed at least 4 weeks before registration
- Prior surgical treatment of stage IV disease is permitted
- CNS metastases
- Prior history of peripheral neuropathy ≥ NCI CTC grade 1
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- Uncontrolled or severe cardiovascular disease
- Serious concurrent infection or nonmalignant illness
- Other malignancy within the past 3 years except cured non-melanomatous skin cancer or carcinoma in situ of the cervix
- Organ allografts requiring immunosuppressive therapy
- Psychiatric disorder or uncontrolled seizure that would preclude compliance
- Pregnant, nursing women or patients with reproductive potential without contraception
- Patients receiving a concomitant treatment with drugs interacting with S-1 such as flucytosine, phenytoin, or warfarin et al.
- Prior unanticipated severe reaction to fluoropyrimidine therapy, or known dihydropyrimidine dehydrogenase (DPD) deficiency
- Known hypersensitivity to platinum compounds or any of the components of the study medications
- Major surgery within 3 weeks prior to study treatment starts, or lack of complete recovery from the effects of major surgery
- Received any investigational drug or agent/procedure, i.e. participation in another trial within 4 weeks before beginning treatment with study drug
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
National Cancer Center Korea
Goyang-si, Gyeonggi-do, 410-769
Kyung Hae Jung, M.D.Ph.D, +82-31-920-1611, khjung@ncc.re.kr
Hwa Jeong Kim, +82-31-920-1145, ncccoloonco@hanmail.net
About this study
Official title: Phase II Study of S-1 Combined With Irinotecan and Oxaliplatin in Patients With Previously Untreated Metastatic Colorectal Cancer
Patients will be treated with irinotecan (150 mg/m2) followed by oxaliplatin (85 mg/m2) on day 1 and S-1 (80 mg/m2/day) from day 1 to 14 every 3 weeks. Patients will receive up to a planned treatment of maximum 12 cycles of chemotherapy. Response assessment will be performed every 2 cycles of chemotherapy.
- Conditions
- Colorecal Neoplasms, Secondary
- Being tested
- S-1, irinotecan, oxaliplatin
- Keywords
- colorectal neoplasms, secondary, Combination chemotherapy, S-1, irinotecan, oxaliplatin
- Medical subject headings
- Neoplasm Metastasis, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S-1, irinotecan, oxaliplatinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal overall response rate
Measured: During chemotherapy
Secondary outcomes (1)
Progression-free survival, Overall survival, Toxicity assessment, & Pharmacokinetic characteristics and association with genetic polymorphism
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2007 (estimated)
- Study startJul 2007
- Study completionJun 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorecal NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Center, Korea
- Sponsor type
- Other government
- Investigators
- Kyung Hae Jung, M.D.Ph.D., Principal investigator, not affiliated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00506571
- Sponsor's protocol ID
- NCCCTS-07-261
- Acronym
- TIROX2
- Status last verified
- Apr 2007
- First submitted
- 23 Jul 2007
- Last updated
- 25 Jul 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of S-1 Combined With Irinotecan and Oxaliplatin in Patients With Previously Untreated Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT00506571
- Acronym / sponsor ID
- TIROX2 / NCCCTS-07-261
- Conditions
- Colorecal Neoplasms, Secondary
- Keywords
- colorectal neoplasms, secondary, Combination chemotherapy, S-1, irinotecan, oxaliplatin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- National Cancer Center, KoreaOther government
- Study start
- Jul 2007
- Study completion
- Jun 2010 (estimated)
- First posted
- 25 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients will be treated with irinotecan (150 mg/m2) followed by oxaliplatin (85 mg/m2) on day 1 and S-1 (80 mg/m2/day) from day 1 to 14 every 3 weeks. Patients will receive up to a planned treatment of maximum 12 cycles of chemotherapy. Response assessment will be performed every 2 cycles of chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histologically confirmed unresectable or metastatic colorectal cancer, not amenable to surgery or radiation treatment for curative intent
- At least one unidimensional measurable lesion
- ECOG performance status 0-2.
- No prior chemotherapy in metastatic settings, but adjuvant or neo-adjuvant treatment for non-metastatic (M0) disease is allowed if completed at least 6 months prior to initiation of study treatment
- Adequate major organ functions
Key exclusion criteria (17 listed)
- Prior systemic chemotherapy for metastatic disease
- Prior treatment with oxaliplatin or irinotecan
- Prior radiotherapy is permitted if it was not administered to target lesions selected for this study and provided it has been completed at least 4 weeks before registration
- Prior surgical treatment of stage IV disease is permitted
- CNS metastases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| S-1, irinotecan, oxaliplatin | Drug | – |
Primary outcome
Maximal overall response rate
Time frame: During chemotherapy
1 secondary outcome
Progression-free survival, Overall survival, Toxicity assessment, & Pharmacokinetic characteristics and association with genetic polymorphism
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2007.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kyung Hae Jung, M.D.Ph.D. principal investigator
not affiliated
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing S-1, irinotecan, oxaliplatin in people with Colorecal Neoplasms and Secondary, run by National Cancer Center, Korea at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jul 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kyung Hae Jung, M.D.Ph.D (+82-31-920-1611, khjung@ncc.re.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal overall response rate (time frame: During chemotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2007.